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Study on the efficacy and safety of integrated Chinese and Western medicine in the treatment of patients with long coronavirus sequelae: a prospective clinical study

Study on the efficacy and safety of integrated Chinese and Western medicine in the treatment of patients with long coronavirus sequelae: a prospective clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083511
Enrollment
Unknown
Registered
2024-04-26
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

long COVID syndrome

Interventions

Western medicine treatment group:Expectorant mixture + Codeine platycodon tablet + ketotifen fumarate tablet + compound methoxetamine
Treatment group of integrated Chinese and Western medicine:Expectorant mixture + Codeine platycodon platycodon tablet + ketotifen fumarate tablet + compound methoxamine + Qingjin Huatan Decoction

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Voluntary signing of informed consent; (2) Age =18 years old; (3) Patients diagnosed with NCOV infection or self-tested antigens/antibodies found NCOV positive; (4) At least 3 months after COVID-19 infection, fatigue and one residual symptom (such as dyspnea, sleep disorder, cough, loose stool, abdominal distension, anorexia, dizziness, etc.) appear, and the symptoms last for at least 2 months and cannot be explained by other diagnoses. (5) After TCM syndrome differentiation, it is consistent with Qi and Yin deficiency, phlegm and stasis sandwich-heat syndrome type.

Exclusion criteria

Exclusion criteria: (1) Inability to communicate (e.g. cognitive impairment); (2) Known history of allergy to any Chinese herbal medicine; (3) Currently positive for SARS-CoV19 infection; (4) known severe conditions such as cardiovascular, liver or kidney insufficiency, diabetes mellitus, cancer, cerebrovascular diseases and diseases of the blood system; (5) Known pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
TCM symptom and degree score;

Secondary

MeasureTime frame
Chalder Fatigue Scale,CFQ-11;Fatigue Severity Scale,FS;Numeric Rating Scale,NRS;Pain Disability Index;DePaul Symptom Questionnaire-Post-Exertional Malaise,DSQ-PEM;Somatic Symptom Severity,SSS-8;EuroQol-5 Dimensions;World Health Organization Quality of Life-BREF,WHOQOL-BREF;Nottingham Health Profile,NHP;St. George's Respiratory Questionnaire,SGRQ;Modified Medical Research Council,mMRC;Pulmonary function test;6-Minute Walk Test,6MWT;Numeric Rating Scale,NRS;Gastrointestinal Symptom Rating Scale,GSRS;qSOFA;SOFA;APACHE II ;SAPS;MPM ;Organ dysfunction score;

Countries

China

Contacts

Public ContactHuang Zitong

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

syxhzt@sina.cn+86 137 9810 0298

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026